U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 3 . 0 8

Silver Spring, MD 20993

www.fda.gov

May 3, 2019

PerkinElmer Inc.

Brian Ciccariello

Sr. Manager Regulatory Affairs

940 Winter Street

Waltham, MA 02451

Re: K190266

Trade/Device Name: NeoLSD MSMS Kit

Regulation Number: 21 CFR 862.1488

Regulation Name: Lysosomal storage disorder newborn screening test system

Regulatory Class: Class II

Product Code: PQW, PQT, PQU, PQV, QCL, QCM

Dated: February 6, 2019

Received: February 8, 2019

Dear Brian Ciccariello:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced

above and have determined the device is substantially equivalent (for the indications for use stated in the

enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance

with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a

premarket approval application (PMA). You may, therefore, market the device, subject to the general

controls provisions of the Act. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. The general controls provisions of the Act include requirements for annual registration,

listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be

subject to additional controls. Existing major regulations affecting your device can be found in the Code of

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements

concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

has made a determination that your device complies with other requirements of the Act or any Federal

statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

K190266 - Brian Ciccariello Page 2

801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR

803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good

manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)

for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices

Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

for

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)K190266

Device NameNeoLSD MSMS Kit

Indications for Use (Describe)The NeoLSD™ MSMS kit is intended for the quantitative measurement of the activity of the enzymes acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid α glucosidase (GAA), β galactocerebrosidase (GALC), α-galactosidase A (GLA) and α-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Pompe Disease, Krabbe Disease, Fabry Disease, and Mucopolyaccharidosis Type I (MPS I) Disease.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

NeoLSD MSMS Kit with QSight

510(k) Summary

This summary of safety and effectiveness information is supplied in accordance with

the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned number is K190266

Date: February 06, 2019

Submitted by: PerkinElmer Inc

940 Winter Street

Waltham MA 02451

Contact Person: Brian Ciccariello

Tel: 781-663-5651

Trade Name: NeoLSD MSMS Kit

Common Name: NeoLSD MSMS Kit

Regulation: 21 CFR 862.1488

Classification Name: Lysosomal storage disorder newborn screening test system

Classification: 75 Chemistry

Product Code: PQW, PQT, PQU, PQV, QCL, QCM

Predicate device: NeoLSD MSMS Kit (K173829)

NeoLSD MSMS Kit with QSight

Intended Use:

The NeoLSD MSMS Kit is intended for the quantitative measurement of the activity of the

enzymes acid‐β‐ glucocerebrosidase (ABG), acid‐sphingomyelinase (ASM), acid‐α‐glucosidase (GAA),

β‐galactocerebrosidase (GALC), α‐ galactosidase A (GLA) and α‐L‐ iduronidase (IDUA) in dried blood

spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in

screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease,

Niemann‐Pick A/B Disease, Pompe Disease, Krabbe Disease, Fabry Disease, and Mucopolysaccharidosis

Type I (MPS I) Disease.

Device Description:

The NeoLSD MSMS test system uses mass spectrometry to quantitatively measure the activity of six lysosomal enzymes simultaneously from a dried blood spot sample. The NeoLSD MSMS test system is comprised of:

1. NeoLSD MSMS kit, including substrates, internal standards, solutions and controls

The NeoLSD MSMS Kit will contain sufficient reagents and consumables to perform 960 assays

(10 x 96‐well plates) as listed in the following table.

Component Description

Kit insert Instructions for use

QC certificate QC certificate showing the kit lot specific Kit Control results determined by

the manufacturer, and the 1 SD limits.

Internal Standards Substrate Mix 1 vial or several vials of stable‐isotope standards and designed substrates,

the dried substrates and internal standards are a mixture of the 6 synthetic

substrates, the corresponding 6 stable‐isotope labeled internal standards,

and sodium oleate

DBS controls C1, C2, C3 control levels on DBS cassettes, manufactured from human blood

with a hematocrit value of 45–50%.

Assay buffer 1 bottle of 40 mL buffer, ready‐for‐use succinate buffered (pH 4.7) salt solution

Extraction Solution Ethyl acetate

Flow Solvent reconstitution

solvent

The ready‐for‐use Flow Solvent contains acetonitrile, water, and formic

acid.

Incubation/Sampling plate 20 x 96‐well microplate, U‐bottomed

Extraction plate 10 x 96‐deep well microplate

Aluminum foil microplate covers 20 adhesive aluminum foil microplate covers

Microplate covers 10 x adhesive microplate covers

Plate barcode labels 30 plate barcodes

NeoLSD MSMS Kit with QSight

2. The QSight Instrument is comprised of:

o QSight® 210 MD Mass Spectrometer o QSight HC Autosampler MD Instrument Software o QSight Binary Pump MD o Simplicity Instrument control software: o Simplicity Data Processing software (by sample): o PerkinElmer MSMS Workstation Data Processing Software

The NeoLSD MSMS kit evaluates enzyme activities by measuring the product generated when an

enzyme reacts with a synthesized substrate to create a specific end product. The activities of the six

lysosomal enzymes present in a 3.2 mm punch from a dried blood spot (DBS) are simultaneously

measured by the NeoLSD MSMS kit. The punches are incubated with the assay reagent mixture

which contains;

• six substrates, one corresponding to each lysosomal enzyme

• six stable‐isotope mass‐labeled internal standards (IS) each designed to

chemically resemble each product generated

• a buffer to maintain the reaction pH, and to carry inhibitors to limit activity from

competing enzymes if present and additives to enhance the targeted enzyme reactions.

NeoLSD MSMS Kit with QSight

Comparison Chart:

Comparison of the NeoLSD MSMS Kit with the predicate.

NeoLSD MSMS Kit

Characteristics Proposed Device Predicate (K173829)

Intended Use/

Indications for

Use

The NeoLSD MSMS Kit is intended for the

quantitative measurement of the activity of the

enzymes acid‐β‐ glucocerebrosidase (ABG),

acid‐sphingomyelinase (ASM), acid‐α‐

glucosidase (GAA), β‐galactocerebrosidase

(GALC), α‐ galactosidase A (GLA) and α‐L‐

iduronidase (IDUA) in dried blood spots (DBS)

from newborn babies. The analysis of the

enzymatic activity is intended as an aid in

screening newborns for the following

lysosomal storage disorders (LSD) respectively;

Gaucher Disease, Niemann‐Pick A/B Disease,

Pompe Disease, Krabbe Disease, Fabry Disease,

and Mucopolysaccharidosis Type I Disease.

Same

Test

Methodology

Quantitative mass spectrometric enzymatic

activity assay

Same

Instrument /

Software

Platform

PerkinElmer QSight 210MD SMS Screening System: CTC PAL RSI Sample Manager, Spark Holland SPH1240 Binary Pump. Instrument Software: Simplicity, Data Processing software and with the PerkinElmer MSMS Workstation Software

Waters Acquity TQD instrument with MassLynx

v4.1 firmware, with Waters 1525 sample pump,

with Waters 2777c autosampler, with Waters

NeoLynx v4.1 software and with the

PerkinElmer MSMS Workstation Software

Sample Type Punch from dried blood spot specimen Same

Reportable Range (µmol/L/h)

IDUA: 0.19 – 22.3 GAA: 0.31 – 25.3

ABG: 0.79 – 20.0 GLA: 0.80 – 20.4 ASM: 0.16 – 13.8

GALC: 0.20 – 7.75

IDUA: 0.34 – 17.2 GAA: 0.44 – 24.2

ABG: 0.69 – 20.1 GLA: 0.97 – 20.9 ASM: 0.90 – 20.5

GALC: 0.63 – 6.3

Lower Limits of

Measure

(µmol/L/h)

IDUA: LoB=0.044, LoD=0.13, LoQ=0.19 GAA: LoB=0.080, LoD=0.31, LoQ=0.31 ABG: LoB=0.114, LoD=0.79, LoQ=0.79 GLA: LoB=0.519, LoD=0.80, LoQ=0.80 ASM: LoB=0.046, LoD=0.16, LoQ=0.16 GALC: LoB=0.120, LoD=0.20, LoQ=0.20

IDUA: LoB=0.059, LoD=0.24, LoQ=0.34 GAA: LoB=0.073, LoD=0.39, LoQ=0.44 ABG: LoB=0.165, LoD=0.63, LoQ=0.69 GLA: LoB=0.476, LoD=0.97, LoQ=0.97 ASM: LoB=0.110, LoD=0.27, LoQ=0.90 GALC: LoB=0.106, LoD=0.34, LoQ=0.63

NeoLSD MSMS Kit with QSight

Calibrators /

Standards

Molecular Weights & Concentrations of Internal Standards: IDUA: 430.26 / 15.0 μM GAA: 502.32 / 24.0 μM ABG: 390.38 / 20.0 μM GLA: 488.31 / 24.0 μM ASM: 404.40 / 15.0 μM

GALC: 416.40 / 10.0 μM

Same

Controls 3 levels of control material, human blood

based

Same

Expected Values (µmol/L/h)

N 0.1% 0.2% 0.3% 2.5% 97.5% N 0.1% 0.2% 0.3% 2.5% 97.5%

IDUA 2488 1.36 1.51 1.86 3.31 12.55 IDUA 5041 2.06 2.55 2.62 3.82 13.2

GAA 2488 2.32 2.54 2.79 4.23 19.55 GAA 5041 2.33 2.69 2.92 4.28 17.5

ABG 2488 1.40 1.78 1.96 3.66 18.95 ABG 5041 2.85 3.16 3.33 4.74 20.1

GLA 2488 3.83 4.74 5.44 7.59 41.99 GLA 5041 3.04 3.37 3.62 4.81 25.8

ASM 2488 1.32 1.43 1.57 2.32 8.01 ASM 5041 2.12 2.21 2.37 3.15 12.9

GALC 2488 0.80 1.01 1.07 1.62 14.90 GALC 5041 0.43 0.52 0.56 0.95 9.34

Precision

Sample Activity Range

Sample CV% Range

Sample Activity Range

Sample CV% Range

IDUA 0.76-16.4 8.9%-15.8% IDUA 0.92-15.7 8.7%-18.7%

GAA 0.95-24.7 7.3%-12.8% GAA 1.29 – 22.4 6.9%-16.7%

ABG 1.05-14.7 13.9%-22.8% ABG 1.15-19.3 12.5%-23.2%

GLA 1.03-17.6 7.3%-16.1% GLA 1.23-19.3 9.1%-16.1%

ASM 0.56-12.2 8.1%-14.5% ASM 0.92-21.5 10.4%-16.7%

GALC 0.27-7.75 6.4%-13.4% GALC 0.45-5.58 11.4%-22.7%

Summary of Studies:

Precision:

The NeoLSD kit precision was determined based on the recommendations of the CLSI guideline EP5-A2

and presented in the tables below. The variation of the NeoLSD MSMS kit is based on 108

determinations: 54 plates measured over 22 working days, each plate having 2 replicates per sample.

The samples were measured on 3 QSight systems using 3 kit lots.

NeoLSD MSMS Kit with QSight

NeoLSD QSight 22-day precision results.

ABG n Mean Repeatability Within-lab Between-lot Total variation

µmol/L/h SD CV% SD CV% SD CV% SD CV%

1 108 1.05 0.11 10.7 0.24 22.7 0.02 2.4 0.24 22.8

2 108 2.33 0.30 13.0 0.38 16.5 0.11 4.8 0.40 17.2

3 108 6.56 0.71 10.8 0.93 14.1 0.19 2.8 0.95 14.4

4 108 13.0 1.21 9.30 1.73 13.3 0.50 3.9 1.80 13.9

5 108 14.7 2.35 15.9 2.97 20.2 0.29 2.0 2.99 20.3

ASM n Mean Repeatability Within-lab Between-lot Total variation

µmol/L/h SD CV% SD CV% SD CV% SD CV%

1 108 0.56 0.06 10.0 0.08 14.0 0.02 3.9 0.08 14.5

2 108 1.12 0.09 8.1 0.11 9.6 0.05 4.1 0.12 10.4

3 108 3.47 0.24 6.9 0.27 7.7 0.09 2.5 0.28 8.1

4 108 7.40 0.71 9.6 0.83 11.2 0.25 3.3 0.86 11.7

5 108 12.2 1.13 9.3 1.32 10.9 0.40 3.3 1.38 11.4

GALC n Mean Repeatability Within-lab Between-lot Total variation

µmol/L/h SD CV% SD CV% SD CV% SD CV%

1 108 0.27 0.03 10.1 0.04 13.2 0.01 2.1 0.04 13.4

2 108 0.56 0.05 8.3 0.07 12.6 0.02 3.6 0.07 13.1

3 108 2.58 0.18 7.1 0.19 7.3 0.02 0.8 0.19 7.4

4 108 4.74 0.24 5.1 0.30 6.4 0.03 0.6 0.30 6.4

5 108 7.75 0.78 10.0 0.82 10.5 0.34 4.4 0.89 11.4

IDUA n Mean Repeatability Within-lab Between-lot Total variation

µmol/L/h SD CV% SD CV% SD CV% SD CV%

1 108 0.76 0.11 15.1 0.12 15.6 0.02 2.3 0.12 15.8

2 108 1.33 0.12 9.1 0.18 13.5 0.03 2.4 0.18 13.7

3 108 2.71 0.20 7.2 0.25 9.2 0.09 3.3 0.26 9.7

4 108 7.75 0.55 7.0 0.69 8.9 0.04 0.5 0.69 8.9

5 108 16.4 1.78 10.8 2.01 12.2 0.34 2.1 2.04 12.4

NeoLSD MSMS Kit with QSight

GLA n Mean Repeatability Within-lab Between-lot Total variation

µmol/L/h SD CV% SD CV% SD CV% SD CV%

1 108 1.03 0.11 10.7 0.16 15.9 0.03 2.6 0.17 16.1

2 108 2.46 0.19 7.5 0.26 10.4 0.04 1.7 0.26 10.5

3 108 6.44 0.49 7.6 0.64 9.9 0.01 0.2 0.64 9.9

4 108 12.2 0.58 4.8 0.95 7.8 0.20 1.6 0.97 7.9

5 108 17.6 1.15 6.5 1.27 7.2 0.15 0.8 1.28 7.3

GAA n Mean Repeatability Within-lab Between-lot Total variation

µmol/L/h SD CV% SD CV% SD CV% SD CV%

1 108 0.95 0.08 8.4 0.12 12.7 0.02 1.7 0.12 12.8

2 108 2.80 0.22 7.8 0.24 8.5 0.05 1.7 0.24 8.7

3 108 8.01 0.55 6.9 0.58 7.2 0.11 1.4 0.59 7.3

4 108 17.1 1.76 10.3 1.95 11.4 0.29 1.7 1.97 11.5

5 108 24.7 1.54 6.2 1.81 7.3 0.23 0.9 1.82 7.4

Limit of Blank, Detection and Quantification:

The limits of blank and detection were determined according to the CLSI guideline EP17-A2 and

presented in the table below. The limit of blank (LoB) for the NeoLSD MSMS kit is defined as the 95th

percentile of a distribution of blank samples determine with 73 determinations. The limit of detection

(LoD) of the kit is based on 75 determinations done with low level samples for the QSight 210 MD

Screening System.

NeoLSD limit of blank (LoB) and limit of detection (LoD) with QSight.

Enzyme LoB LoD

ABG 0.114 0.79

ASM 0.046 0.16

GALC 0.120 0.20

IDUA 0.044 0.13

GLA 0.519 0.80

GAA 0.080 0.31

NeoLSD MSMS Kit with QSight

The Limit of Quantitation (LoQ) is defined as the lowest activity fulfilling the total CV% requirement of

the assay. For ABG, GLA and IDUA the CV% requirement is <40%. For ASM and GAA <30% and for GALC

<50%. If the imprecision criterion was met for activities below LoD, the LoQ was set to be equal to the

LoD. The table shows the LoQ results and imprecision observed at these activities:

NeoLSD Limit of Quantitation

Enzyme

QSight

LoQ (µmol/L/h)

ABG 0.79

ASM 0.16

GALC 0.20

IDUA 0.19

GLA 0.80

GAA 0.31

Linearity:

Linearity was determined in accordance with CLSI guideline EP06-A. The data fulfills the acceptance

criteria of the study for the PerkinElmer QSight 210 MD Screening System. The linear range for NeoLSD

MSMS kit using the QSight is summarized in below.

NeoLSD linear range

Enzyme

QSight

Linear Range

Lower Limit

(mol/L/h)

Linear Range

Upper Limit

(mol/L/h)

ABG 0.39 20.0

ASM 0.09 13.8

GALC 0.18 7.75

IDUA 0.08 22.3

GLA 0.60 20.4

GAA 0.11 25.3

Interference:

Refer to the kit insert for interference information.

NeoLSD MSMS Kit with QSight

Screening Performance:

The screening performance of the NeoLSD MSMS kit on QSight and Waters Acquity TQD was compared in a clinical study at US newborn screening laboratory (Site A). In the study 2489 routine newborn samples were tested. Samples tested were from newborns ≤ 48 hours old. The study population was enriched with 12 archived confirmed LSD positive newborn DBS specimens.

The initial cut-off values were based on a percentage of population median activity. The retest cut-off values were set 5% lower from the initial cut-off percentage. The cut-off percentages were applied to daily medians established based on the initial routine sample results for the day. The initial and retest cut-off percentages used in the study are shown below. The final results for the screening performance including confirmed positive specimens are presented below. Two retrospective confirmed positive Krabbe specimens and one routine specimen were categorized as “invalid result”. In routine newborn screening, if a specimen result is categorized as invalid result, a new dried bloodspot specimen should be obtained, and retesting performed using age-specific cut-off values. Invalid results are excluded from the tabulations.

Descriptive statistics for the US Site A.

QSight

Initial cut-off

Retest cut-off

Enzyme

n

Enzyme activity (mol/L/h)

Range*

Mean

Median Lower percentiles

0.1% 0.2% 0.3%

ABG 2489 1.06 – 102 9.47 8.83 1.40 1.78 1.96 25% 20%

ASM 2489 1.09 – 23.7 4.55 4.30 1.32 1.43 1.57 35% 30%

GALC 2489 0.48 – 50.0 5.57 4.70 0.80 1.01 1.07 25% 20%

IDUA 2489 0.34 – 21.0 7.30 7.05 1.36 1.51 1.86 25% 20%

GLA 2489 2.21 – 133 17.5 15.3 3.83 4.74 5.44 35% 30%

GAA 2489 1.87 – 31.8 10.1 9.53 2.32 2.54 2.79 25% 20%

TQD

Initial cut-off

Retest cut-off

Enzyme

n

Enzyme activity (mol/L/h)

Range*

Mean

Median Lower percentiles

0.1% 0.2% 0.3%

ABG 2489 1.09 – 104 9.17 8.50 1.36 1.70 1.88 25% 20%

ASM 2489 1.11 – 24.2 4.63 4.39 1.36 1.43 1.60 35% 30% GALC 2489 0.43 – 47.0 5.08 4.25 0.68 0.85 0.92 25% 20%

IDUA 2489 0.32 – 21.3 7.24 6.99 1.34 1.44 1.83 25% 20%

GLA 2489 1.84 – 144 16.9 14.6 3.64 4.27 4.79 35% 30%

GAA 2489 1.92 – 35.6 10.9 10.2 2.40 2.65 2.88 25% 20% * Some results were outside the measuring range and cannot be considered accurate (see section “REPORTING

RESULTS”).

NeoLSD MSMS Kit with QSight

Screening performance using percentage of daily median cut-off (Invalid results and samples with no repeat result excluded).

Gaucher (ABG) TQD

Screening Positive Screening Negative Total

QSight

Screening

Positive 3* 0 3

Screening Negative

0 2487 2487

Total 3 2487 2490

*Includes 2 retrospective confirmed positive samples

Niemann-Pick A/B (ASM) TQD

Screening Positive Screening Negative Total

QSight

Screening

Positive 2* 0 2

Screening

Negative 0 2488 2488

Total 2 2488 2490

*Includes 1 retrospective confirmed positive sample

Krabbe (GALC) TQD

Screening Positive Screening Negative Total

QSight

Screening

Positive 4* 0 4

Screening Negative

0 2486 2486

Total 4 2486 2490

*Includes 1 retrospective confirmed positive sample

MPS I (IDUA) TQD

Screening Positive Screening Negative Total

QSight

Screening

Positive 6* 0 6

Screening Negative

0 2484 2484

Total 6 2484 2490

*Includes 1 retrospective confirmed positive sample

NeoLSD MSMS Kit with QSight

Fabry (GLA) TQD

Screening Positive Screening Negative Total

QSight

Screening

Positive 6* 0 6

Screening Negative

0 2484** 2484

Total 6 2484 2490

* Includes 2 retrospective confirmed positive samples **Includes 2 retrospective confirmed positive female samples

Pompe (GAA) TQD

Screening Positive Screening Negative Total

QSight

Screening

Positive 1* 0 1

Screening Negative

0 2489 2489

Total 1 2489 2490

*Includes 1 retrospective confirmed positive sample Conclusion: The NeoLSD MSMS kit demonstrates analytical and screening performance that supports its substantial equivalency with the predicate device, NeoLSD MSMS kit (K173829).